Table 3.
Treatment-Related Adverse Events by MedDRA Preferred Term in the Double-Blind and Open-Label Periods
| Preferred term | Placebo (n=13) | Abrilumab |
||
|---|---|---|---|---|
| 21 mg (n=10) | 70 mg (n=12) | 210 mg (n=9) | ||
| Double-blind period | ||||
| Any adverse event | 2 (15.4) | 2 (20.0) | 0 | 1 (11.1) |
| Malaise | 0 | 0 | 0 | 1 (11.1) |
| Injection site swelling | 1 (7.7) | 0 | 0 | 0 |
| Headache | 0 | 1 (10.0) | 0 | 1 (11.1) |
| Enterocolitis viral | 1 (7.7) | 0 | 0 | 0 |
| White blood cell count decreased | 0 | 1 (10.0) | 0 | 0 |
| Asthma | 0 | 1 (10.0) | 0 | 0 |
| Open-label period | ||||
| Any adverse event | 4 (33.3) | 3 (30.0) | 2 (16.7) | 1 (14.3) |
| Colitis ulcerative | 0 | 0 | 2 (16.7) | 1 (14.3) |
| Enteritis | 0 | 0 | 1 (8.3) | 0 |
| Influenza | 1 (8.3) | 0 | 0 | 0 |
| Nasopharyngitis | 0 | 1 (10.0) | 0 | 0 |
| Sinusitis | 0 | 1 (10.0) | 0 | 0 |
| Anemia | 1 (8.3) | 0 | 0 | 0 |
| Lymphadenitis | 1 (8.3) | 0 | 0 | 0 |
| Cough | 1 (8.3) | 0 | 0 | 0 |
| Allergic cough | 1 (8.3) | 0 | 0 | 0 |
| Edema peripheral | 0 | 1 (10.0) | 0 | 0 |
| Gall bladder polyp | 1 (8.3) | 0 | 0 | 0 |
| Pain in extremity | 0 | 1 (10.0) | 0 | 0 |
| Genital hemorrhage | 0 | 0 | 1 (8.3) | 0 |
Values are presented as number (%). Preferred terms in this table were coded using Medical Dictionary for Regulatory Activities (MedDRA) version 19.1.